Director, Promotional Regulatory Affairs

Job Description

The Director, Promotional Regulatory Affairs is responsible for providing regulatory review of advertising and promotional materials, and other Commercial and Medical Affairs communications, in order to ensure compliance with company policies, FDA regulations and guidelines, and other Health Agency regulations. The position also provides strategic and operational regulatory leadership concerning advertising and promotional issues to assigned project teams.

Essential Functions of the Job:

• Works closely with representatives from Marketing, Legal, and Medical Affairs in the development of advertising and promotional materials.
• Ensures compliance with applicable FDA and state regulations and those of other Regulatory Agencies.
• Provides input into labeling, company-sponsored educational seminars, content of displays at major meetings, responses to physician inquiries, and other communications.
• Ensures advertising and promotional materials are updated to be consistent with current labeling.
• Delivers regulatory compliance training to members of cross-functional teams as needed.
• Participates in the development of commercial compliance policies to support the commercial interests of the business.
• Serves as point of contact with the FDA Office of Prescription Drug Promotion (OPDP) and directs the timely submission of all applicable approved promotional materials to the FDA and to other Regulatory Agencies, as required.
• Manages the maintenance of records and databases that support communication with OPDP and other Regulatory Agencies.
• Maintains awareness of the promotional regulatory environment with the FDA and understands international/global promotional issues.

Qualifications:

• BS/MS or Ph.D., PharmD in a scientific discipline or equivalent experience.
• Minimum of 5 years experience in pharmaceutical industry that includes direct experience in promotion and advertising and commercial compliance in a high growth, fast-paced pharmaceutical environment.
• Direct experience as liaison with OPDP.
• Broad knowledge of Labeling, Advertising and other applicable regulations.
• Knowledgeable in both State and Federal requirements regarding commercial compliance in advertising and promotion.
• Experience in oncology/accelerated approval promotion would be advantageous.
• Knowledge and experience of European/International requirements for promotion of ethical pharmaceuticals would be advantageous.

Equal Opportunity Employer

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.

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